Regulatory navigation - a starter pack for researchers

Project overview

It is essential that founders of science-based startups are prepared to encounter regulatory challenges.

Regulation can pose a major roadblock to the ambitions of new founders, and regulatory non-compliance ranks among the primary reasons new startups fold.¹ Regulatory requirements are significantly more stringent in industry than in academia, and it is essential to treat regulations seriously and build a clear strategy for handling them early on. Founders can reassure investors by demonstrating an early understanding of regulations and industry-relevant standards in their business plan.

This resource has therefore been developed to help MacDiarmid-affiliated startup founders – who may have limited to no prior experience of the regulatory environment – navigate the complex regulatory space. This critical examination may also prove useful to regulators and policy makers with an R&D focus.

Different topics of interest to startup founders. The overarching goal of the Regulatory Navigation project is to increase founder awareness of regulatory challenges they might face when scaling up, and to enable them to be proactive about overcoming these challenges.

These topics of interest can be reframed as the following key questions for a founder to consider:

1. How can I scale up effectively by progressively retiring regulatory risk while transitioning from lab to market?
2. How can I build a product strategy where the target markets at different stages of startup growth are tailored to the regulatory landscape?
3. How can I perform a life-cycle analysis that ensures our products are compatible with standards and regulations relevant to our target market?
4. How can I build in-house expertise regarding complex regulatory requirements?

As these questions are rather broad in scope, this resource does not attempt to address each point in detail. Instead, it aims to help founders consider these questions through a series of case studies on regulatory challenges faced by local startups when scaling up. These case studies place examples of these challenges alongside a description of how they were addressed by the startup. For example, a hypothetical advanced computing startup might handle data from Māori sources.² A case study might then illustrate how a startup drew upon resources like the Wai 262 Waitangi Tribunal report to ensure indigenous rights and interests were being protected when developing their product.³